A Phase 2/3 interventional study of Rupatadin in Mastocytosis, sponsored by Marcus Maurer. Completed at 1 site in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-11-03.
Sponsored by Marcus Maurer · Phase 2/3, Interventional, and Treatment
Study title:
An exploratory, randomised, double-blind, placebo controlled crossover study to assess the efficacy of 20 mg Rupatadine on the treatment of mastocytosis symptoms.
Study code:
SMART-2010-1 Principal Investigator, Co-Investigator, sponsor, and study centre (acc. to § 40 Abs. 4 AMG) Dr. med. F. Siebenhaar, Prof. Dr. Med. M. Maurer, Allergie-Centrum-Charité, Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin, Charitéplatz 1, D-10117 Berlin Biometry and biostatistical analyses Division of Biostatistics and Clinical Epidemiology, Charité - Universitätsmedizin Berlin, Charitéplatz 1, D-10117 Berlin Monitoring Coordination Centre for Clinical Studies (KKS), Charité - Universitätsmedizin Berlin, Charitéplatz 1, D-10117 Berlin Clinical phase Phase II
Primary objective:
Reduction of wheal and flare type skin reaction after standardised provocation testing assessed by volumetric and thermographic measurements.
Secondary objectives:
Improvement of additional related symptoms (e.g. pruritus) and subjective affliction as assessed by symptom score, DLQI, Itchy-QoL and VAS.
Study design:
An exploratory, randomised, double-blind, placebo controlled crossover study
Type and number of patients:
Male and female patients (n = 30) with cutaneous mastocytosis and indolent systemic mastocytosis with skin involvement
Main criteria for inclusion:
Mastocytosis patients aged 18-65 years, signed written consent, no systemic corticosteroid or other immunosuppressive therapy, no permanent severe diseases Test product, dose and mode of administration 20 mg Rupatadine or placebo before provocation testing, oral administration (tablets)
Duration of treatment:
28 days (testing will be done at the day of last treatment)
Assessment of efficacy:
Main criteria of evaluation:
Efficacy
77 studies on the registry are indexed under Mastocytosis; 16 are open to participants now.
This study's enrollment of 30 is close to the median of 30 across 43 interventional studies indexed under Mastocytosis.
Browse Mastocytosis studies →Marcus Maurer is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
All patients included in this study will be subjected at the screening visit to a standardized provocation of Darier's sign by a device for standardized provocation testing (Hartmann and Siebenhaar 2009). Patients that exhibit positive skin test reactions will be enrolled, provided that they meet all inclusion criteria and none of the exclusion criteria and that they give informed consent. Study patients will receive treatment for 28 days (minimal 25, maximal 30 days) before visit 1 and visit 2 including the same day before the provocation test (RUP 20mg/day or placebo according to randomization). All patients will receive antihistaminic rescue medication immediately after completing the testing when necessary.
Drug: Rupatadin
All patients included in this study will be subjected at the screening visit to a standardized provocation of Darier's sign by a device for standardized provocation testing (Hartmann and Siebenhaar 2009). Patients that exhibit positive skin test reactions will be enrolled, provided that they meet all inclusion criteria and none of the exclusion criteria and that they give informed consent. Study patients will receive treatment for 28 days (minimal 25, maximal 30 days) before visit 1 and visit 2 including the same day before the provocation test (RUP 20mg/day or placebo according to randomization). All patients will receive antihistaminic rescue medication immediately after completing the testing when necessary.
Drug: Rupatadin
20 mg, 28 days over 60 days
Also known as: Each tablet contains 10 mg RUP
Pruritus
Reduction of pruritus and wheal and flare type skin reaction after standardised provocation testing as assessed by volumetric and thermographic measurements.
Time frame: 10 weeks
Questionaire
Improvement of additional disease related symptoms and subjective affliction as measured by physician and patient global assessments, DLQI, Itchy-QoL and QoL(i)MaP\*. \*not validated questionnaire for mastocytosis symptoms
Time frame: 10 weeks
The record gives a start of Sep 2010, a primary completion of Aug 2011 and a completion of Nov 2011. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Marcus Maurer